Randomized controlled trial of cholecalciferol supplementation in chronic kidney disease patients with hypovitaminosis D

Marckmann, Peter; Agerskov, Hanne; Thineshkumar, Sasikala; Bladbjerg, Else‐Marie; Sidelmann, Johannes Jakobsen; Jespersen, Jørgen; Nybo, Mads; Rasmussen, Lars Melholt; Hansen, Ditte; Scholze, Alexandra

doi:10.1093/ndt/gfs138

Cited by 124 publications

(147 citation statements)

References 43 publications

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“…43 Potential harms with nutritional vitamin D supplementation include hypercalcemia, hyperphosphatemia, and extraskeletal ossification. In our study, in which 80% or more were concomitantly treated with VDRAs, there were no significant changes in calcium or phosphorus, and this is consistent with all of the other RCTs in patients on hemodialysis, 19,[22][23][24][25][26][27]31,[33][34][35] including one study that administered 200,000 IU of cholecalciferol weekly for 3 weeks. 27 Raising the possibility that there may be harmful outcomes associated with excess nutritional vitamin D administration, an RCT in community dwelling elderly women treated with a one-time dose of 500,000 units of ergocalciferol or placebo found a 15% increase in falls and a 26% increase in fractures in the ergocalciferol arm at 1 year.…”

Section: Discussionsupporting

confidence: 89%

“…There have been ten previous RCTs with sample size $30 patients and follow-up $8 weeks that have assessed the effects of nutritional vitamin D or calcifediol supplementation in patients on dialysis on iPTH, 19,[22][23][24][25][26][27]31,[33][34][35] and all but one small study 33 is consistent with the present study in finding no effect on iPTH. An absence of effect of nutritional vitamin D on iPTH has also been found in stage IV CKD, 36,37 while at earlier stages of CKD, there appears to be a reduction in iPTH with nutritional vitamin D. The conclusion from a Cochrane evidence review, published in 2009 before many of the above-mentioned trials were completed, concluded that vitamin D is effective in suppressing iPTH, although (not obvious from the abstract) this statement pertains to VDRAs and not to nutritional vitamin D. 38 The results of observational studies lead one to believe that there is a reduction in iPTH in patients on hemodialysis with nutritional vitamin D supplementation, 6,8,18,39 although these studies used historical controls and are limited by other biases inherent with a nonrandomized design.…”

Section: Discussionsupporting

confidence: 82%

“…28,29 Prior RCTs that have measured inflammation in patients on hemodialysis after vitamin D supplementation have not found reductions in cytokines or T-cell or monocyte mediators. 24,30,31 The observation of an acute decline from baseline in serum 25(OH)D drawn 48 hours after surgery has even led to the suggestion that serum 25(OH)D is a negative acute-phase reactant. 32 The current study furthers the skepticism about the therapeutic role for nutritional vitamin D in reducing inflammation by showing no effect of increasing serum 25 (OH)D on epoetin responsiveness or hsCRP levels.…”

Section: Discussionmentioning

confidence: 99%

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Ergocalciferol Supplementation in Hemodialysis Patients With Vitamin D Deficiency: A Randomized Clinical Trial

Miskulin

Majchrzak²,

Tighiouart

et al. 2015

JASN

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Locally produced 1,25-dihydroxyvitamin D3 may have pleiotropic effects outside of bone. Experimental and observational studies suggest that nutritional vitamin D may enhance erythropoiesis in settings of 25-hydroxy vitamin D (25(OH)D) deficiency. We conducted a double-blind, placebo-controlled, randomized clinical trial to assess the effects of supplementation with ergocalciferol on epoetin utilization and other secondary outcomes in patients on hemodialysis with serum 25(OH)D ,30 ng/ml. In all, 276 patients were randomized to 6 months of ergocalciferol or placebo. Mean6SD serum 25(OH)D increased from 16.065.9 ng/ml at baseline to 39.2614.9 ng/ml in the ergocalciferol arm and did not change (16.966.4 ng/ml and 17.567.4 ng/ml, respectively) in the placebo arm. There was no significant change in epoetin dose over 6 months in the ergocalciferol or placebo arms (geometric mean rate 0.98 [95% confidence interval (95% CI), 0.94 to 1.02] versus 0.99 [95% CI, 0.95 to 1.03], respectively) and no difference across arms (P=0.78). No change occurred in serum calcium, phosphorus, intact parathyroid hormone, or C-reactive protein levels, cinacalcet use, or phosphate binder or calcitriol dose in either study arm. Rates of all-cause, cardiovascular, and infection-related hospitalizations did not differ by study arm, although statistical power was limited for these outcomes. In conclusion, 6 months of supplementation with ergocalciferol increased serum 25(OH)D levels in patients on hemodialysis with vitamin D insufficiency or deficiency, but had no effect on epoetin utilization or secondary biochemical and clinical outcomes.

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Section: Discussionsupporting

confidence: 89%

Section: Discussionsupporting

confidence: 82%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Ergocalciferol Supplementation in Hemodialysis Patients With Vitamin D Deficiency: A Randomized Clinical Trial

Miskulin

Majchrzak²,

Tighiouart

et al. 2015

JASN

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“…32 Cholecalciferol supplementation of 40,000 IU every week for 8 weeks had no significant impact on both PWV and Alx@75 in CKD patients as previously shown. 33 In another study, Chitalia et al 32 administered two doses of 300,000 IU cholecalciferol at baseline and 8-weeks to CKD stage 3-4 patients, PWV decreased from 7.9±1.9 to 7.7±2.2 m/s and Alx decreased from 22±16% to 18±20% at week 16. However, they concluded that PWV and Alx tended to improve but did not reach statistical significance.…”

Section: Discussionmentioning

confidence: 97%

Arterial stiffness and 25-hydroxyvitamin D levels in chronic kidney disease patients

Akdam

Alp

2017

Rev. Assoc. Med. Bras.

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“…De fato, é reportado que o tratamento com colecalciferol mantém ou aumenta os níveis de calcitriol. 27,28 Além disso, a 25-hidroxivitamina D parece agir diretamente no VDR, osteoclastos e osteoblastos. 29 Outro emprego da vitamina D parece ser em pacientes com proteinúria maciça, em que ocorre perda urinária substancial de DBP, levando à queda dos níveis de 25-hidroxivitamina D. 30,31 Como é fisiologicamente plausível que a vitamina D exerça diversos efeitos biológicos, e evidências epidemioló-gicas e observacionais sugerem que exista uma relação causal entre hipovitaminose e complicações relacionadas a DRC, o Kidney Diasease Improving Global Outcomes (KDIGO) posicionou-se, sugerindo a aferição rotineira dos níveis de vitamina D em pacientes com DRC estágios 3-5D, usando as recomendações para a população geral para sua correção (Grau de recomendação 2C).…”

Section: Doença Renal Crônicaunclassified

Reposição de vitamina D nativa: indicação à luz das evidências científicas atuais

Gonella

Muniz

Pereira

et al. 2016

Rev. Fac. Ciênc. Méd. Sorocaba

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RESUMOO papel da vitamina D nativa na fisiologia do tecido ósseo é evidente não só como um nutriente essencial capaz de prevenir e tratar o raquitismo mas também como regulador da homeostase do cálcio, fosfato e do metabolismo ósseo. Um amplo espectro de ações biológicas tem sido descrito, incluindo efeitos sobre os sistemas cardiovascular, nervoso central e imune, na diferenciação e crescimento celular, bem como no controle de outros sistemas hormonais. Evidências epidemiológicas associaram estados de déficit de vitamina D com doenças como câncer, diabetes mellitus, hipertensão arterial, doenças autoimunes, infecções e aumento da mortalidade. O conjunto dessas informações levou à medicalização da vitamina D, acarretando seu uso em diversas doenças, e até mesmo em situações clínicas questionáveis. No entanto, os resultados de estudos clínicos apontam para resultados divergentes, colocando em questão o uso indiscriminado da vitamina D. Este artigo apresenta uma revisão sobre a vitamina D e relaciona algumas das principais evidências científicas sobre os reais benefícios de sua suplementação em seres humanos em diversas condições. Palavras-chave: vitamina D; deficiência de vitamina D; estudo clínico. ABSTRACTThe role of native vitamin D in the bone tissue physiology is clear not only as an essential nutrient able to treat and prevent rickets but also as a regulator of calcium and phosphate homeostasis, as of bone metabolism. A wide spectrum of biological activities has been described, including effects on cardiovascular, central nervous, and immunological systems, INTRODUÇÃOA identificação e a compreensão das funções clássicas da vitamina D ocorreram no início do século XX, quase três séculos após a primeira descrição do raquitismo. Nas dé-cadas seguintes, tornou-se evidente o papel da vitamina D na fisiologia do tecido ósseo não só como um nutriente essencial capaz de prevenir e tratar o raquitismo mas também como regulador da homeostase do cálcio (Ca), fosfato (P) e o do metabolismo ósseo. Pesquisas subsequentes evidenciaram que as ações da vitamina D são amplas, com efeitos sobre os sistemas cardiovascular, nervoso central e imune, diferenciação e crescimento celular, e controle de outros sistemas hormonais. 1 Ao mesmo tempo, evidências epidemiológicas associaram a carência de vitamina D com doenças como câncer, diabetes mellitus, hipertensão arterial, doenças autoimunes, infecções e aumento da mortalidade em determinados grupos.1,2 O conjunto dessas informações levou à medicalização da vitamina D sob um pano de fundo contendo mensagens divergentes: de um lado, evitar a exposição à radiação solar para prevenção de câncer de pele e, de outro, seu uso em diversas doenças e até mesmo em situações clínicas questionáveis.

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Randomized controlled trial of cholecalciferol supplementation in chronic kidney disease patients with hypovitaminosis D

Cited by 124 publications

References 43 publications

Ergocalciferol Supplementation in Hemodialysis Patients With Vitamin D Deficiency: A Randomized Clinical Trial

Ergocalciferol Supplementation in Hemodialysis Patients With Vitamin D Deficiency: A Randomized Clinical Trial

Arterial stiffness and 25-hydroxyvitamin D levels in chronic kidney disease patients

Reposição de vitamina D nativa: indicação à luz das evidências científicas atuais

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